Actively Recruiting
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Led by Devyser Inc. · Updated on 2025-12-17
400
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA dd-cfDNA to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organs status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA gDNA samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.
CONDITIONS
Brief Title
A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Is 18 years of age or older at enrollment
- Had a kidney transplant prior to enrollment
- Is having an indication (for cause) biopsy as determined by clinician
- Retrospective leftover samples are available from the kidney donor(s)
You will not qualify if you...
- Is pregnant
- Had a blood transfusion within the past 4 weeks
- Had a transplant from an identical (monozygotic) twin
- Had transplants of multiple organs from the same donor (eg, kidney and liver transplant)
- Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
- Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
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